Agency Response Letter GRAS Notice No. GRN 000466
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CFSAN/Office of Food Additive Safety
September 25, 2013
Timothy B. Adams, Ph.D.
7325 Bannockburn Ridge Court
Bethesda, MD 20817
Re: GRAS Notice No. GRN 000466
Dear Dr. Adams:
The Food and Drug Administration (FDA) is responding to the notice, dated November 19, 2012, that you submitted on behalf of McCormick and Company, Inc. (McCormick) in accordance with the agency’s proposed regulation, proposed 21 CFR 170.36 (62 FR 18938; April 17, 1997; Substances Generally Recognized as Safe (GRAS); the GRAS proposal). FDA received the notice on March 1, 2013, filed it on April 3, 2013, and designated it as GRAS Notice No. GRN 000466.
The subject of the notice is polyglycerol polyricinoleic acid (PGPR). The notice informs FDA of the view of McCormick that PGPR is GRAS, through scientific procedures, for use as an emulsifier in condiments and spreads at levels up to 0.28%, in flavors at levels up to 0.1%, and in snacks (cheese powders) at levels up to 0.15%.
McCormick incorporates by reference four GRAS notices regarding use of PGPR as an emulsifier (GRNs 000009, 000179, 000053, 000266, and 000270).
PGPR is a polymer of glycerol esterified with ricinoleic acid. It is a clear, light brown, viscous liquid, and is insoluble in water and alcohol. The CAS registry number is 29894-35-7. McCormick states that its PGPR complies with the specifications for PGPR in the Sixth Edition of the Food Chemical Codex, including a specification for lead (≤1 milligram per kilogram (mg/kg)).
McCormick describes the manufacturing process for PGPR. The starting materials are glycerol and castor oil fatty acids, which are comprised of 80% to 90% ricinoleic acid. Condensation of ricinoleic acid is carried out by heating castor oil fatty acids to 200°C with or without a catalyst and removing the water of reaction. Acceptable catalysts are acids such as phosphoric acid, bases such as sodium hydroxide, and lipase enzymes. The esterification of polyglycerol with ricinoleic acid results in the formation of the final product. McCormick states that PGPR is produced in accordance with current good manufacturing process using food grade ingredients.
McCormick estimates the daily dietary exposure to PGPR from the intended use level in each food and the expected number of servings of each food consumed per day. This resulted in an estimated dietary exposure to PGPR of 4.17 mg per kg of body weight per day (mg/kg bw/d) for a 60-kg person. McCormick also estimates the exposure to PGPR from the food uses that were the subjects of the previous GRAS notices to estimate a cumulative exposure to PGPR.1 The estimated dietary exposures for the uses of PGPR in chocolates (GRNs 000009 and 000266) in color additive mixtures (GRN 000270) were 2.4 mg/kg bw/d and 0.25 mg/kg bw/d, respectively. Therefore, the McCormick calculated the cumulative estimated dietary exposure to PGPR for all the food uses as 6.82 mg/kg bw/d.
McCormick reviews the published data supporting the safe use of PGPR in foods, noting also that previous GRAS notices (GRN 000009, 000179, 000266, and 000270) have reviewed the safety of PGPR. McCormick discusses the metabolism of PGPR, noting that intestinal lipase catalyzes the hydrolysis of PGPR following ingestion. McCormick considers that data on the hydrolysis product ricinoleic acid to also be relevant to the safety evaluation of PGPR. McCormick cites published studies indicating that ricinoleic acid is readily incorporated into normal fatty acid metabolism and is well-tolerated. McCormick reviews a published two-year study in which rats consumed up to 750 mg/kg bw/day of PGPR with no adverse effects. Further, McCormick notes that emulsifier uses of PGPR were concluded to be safe by the Joint FAO/WHO Expert Committee on Food Additives and the European Scientific Committee for Food.
Based on the data and information summarized above, McCormick concludes that PGPR is GRAS for the intended uses in foods.
Standards of Identity
In the notice, McCormick states its intention to use PGPR in several food categories, including foods for which standards of identity exist, located in Title 21 of the Code of Federal Regulations. We note that an ingredient that is lawfully added to food products may be used in a standardized food only if it is permitted by the applicable standard of identity.
Section 301(ll) of the Federal Food, Drug, and Cosmetic Act (FD&C Act)
The Food and Drug Administration Amendments Act of 2007, which was signed into law on September 27, 2007, amends the FD&C Act to, among other things, add section 301(ll). Section 301(ll) of the FD&C Act prohibits the introduction or delivery for introduction into interstate commerce of any food that contains a drug approved under section 505 of the FD&C Act, a biological product licensed under section 351 of the Public Health Service Act, or a drug or a biological product for which substantial clinical investigations have been instituted and their existence made public, unless one of the exemptions in section 301(ll)(1)-(4) applies. In its review of McCormick’s notice that PGPR is GRAS for the intended uses, FDA did not consider whether section 301(ll) or any of its exemptions apply to foods containing PGPR. Accordingly, this response should not be construed to be a statement that foods that contain PGPR, if introduced or delivered for introduction into interstate commerce, would not violate section 301(ll).
Based on the information provided by McCormick, as well as other information available to FDA, the agency has no questions at this time regarding McCormick’s conclusion that PGPR is GRAS under the intended conditions of use. The agency has not, however, made its own determination regarding the GRAS status of the subject use of PGPR. As always, it is the continuing responsibility of McCormick to ensure that food ingredients that the firm markets are safe, and are otherwise in compliance with all applicable legal and regulatory requirements.
In accordance with proposed 21 CFR 170.36(f), a copy of the text of this letter responding to GRN 000466, as well as a copy of the information in this notice that conforms to the information in the GRAS exemption claim (proposed 21 CFR 170.36(c)(1)), is available for public review and copying at www.fda.gov/grasnoticeinventory.
Dennis M. Keefe, Ph.D.
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
1McCormick notes that the uses of PGPR described in GRN 000466 include the uses described in GRN 000179. Thus, McCormick’s cumulative exposure estimate that includes the estimated daily intake exposure from GRN 000466 subsumes the exposures described in GRN 000179.